External Factors Impacting New Oncology Products
Two of the biggest external factors impacting new oncology pharmaceutical products coming onto the market are pricing and legalities. Below is an overview of the findings on this subject matter.
EXTERNAL FACTORS IMPACTING NEW ONCOLOGY PRODUCTS
- When new products are launched, the prices are generally high and keep increasing.
- Prices that increase over 16% in 24 months need to be reported (60 days’ notice).
- Generic brands or copy-cat brands tend to sell products at a lower price which may attract more consumers.
- The U.S. government limits prescription drug prices that are made by manufactures.
- President Donald Trump has made note of the high drug prices and implored Medicare to negotiate lower prices.
- Stakeholders have expressed concerns about the escalating prices with improved innovations as they would rather have a reduction in cost and improved quality.
- To gain more access to drugs, payers are looking for alternative payment options such as the Oncology Care Model (currently restricted to chemotherapy) and the Accountable Care Organizations.
- A company entering the market with new products would likely face challenges because oncology patients get financial assistance for medications. Consequently, a high-priced drug would not be easily sold.
- Biosimilars are facing lawsuits over biologic patents, which is affecting its growth rate on the market.
- Companies have to engage in expensive clinical trials before they can enter the market.
- New products also require prior authorizations.
- Legislation is being put in place to control pricing at the state and federal level and California is leading in this area.
- There is legislation, regulations, and advocacy that companies must adhere to in order to market and advertise their products to consumers, strongly supported by the American Medical Association.
- President Donald Trump, in a State of the Union Address, shed light on a policy that allows patients who are terminally ill to access unapproved drugs through the right-to-try legislation. This could pose a challenge for companies that are producing new products in the same area as patients could be less interested in their products if they are offered at high prices.
- It also reduces the number of patients who would once be interested in clinical trials.
- New products that are supported by the American Society of Clinical Oncology (ASCO) are likely to see an increase in use.
For this research, we defined the biggest external factors as the most talked about issues that companies with new oncology pharmaceutical products are facing as described in research, news, industry reports, market trend reports, consulting and blogs. We used sources such as NAP, Gentech Forum, Blue Matter Consulting, Pro Clinical Blog and Biologics Inc. to answer the question. The selected external factors appeared a minimum of six times across sources which are all in the U.S. market for oncology pharmaceutical products.